To National and International Hand Surgeons:

New treatment for Carpal Tunnel Syndrome
Balloon Carpal Tunnel-Plasty

Dear Colleague:

We are conducting a FDA approved clinical study of a new surgical
procedure for the treatment of carpal tunnel syndrome.

It is called Balloon Carpal Tunnel-Plasty and, like the angioplasty of
heart procedures, this new method relies on a balloon to stretch rather
than cut the transverse carpal ligament.
The principle is that by stretching the ligament, the size of the tunnel
is increased and stretching the ligament decreases pressure on the
median nerve. There is no cutting in the carpal tunnel.

The new technique, Balloon Carpal Tunnel-Plasty, requires specialized
equipment designed for this procedure.
It involves the use of a balloon catheter device, which is built into a
specialized nerve protector to stretch and expand the transverse carpal
ligament relieving the symptoms of carpal tunnel syndrome.

The procedure is performed through a one-centimeter size incision at the
distal palmar crease ulnar to the palmaris longus in
line with the fourth ray. The approach is identical to the single portal
endoscopic technique.

Balloon Carpal Tunnel-Plasty avoids transection of the transverse carpal
ligament, which we feel serves a protective purpose in the hand. We
believe that by not cutting the ligament there will be less alteration
of the biomechanics of the hand. The procedure should decrease the
incidence of scar formation and perineural fibrous in the carpal tunnel
that is common after open or endoscopic carpal tunnel release procedures
that cut the ligament.The patient should have a very rapid recovery
period with early return to activities of daily living. We feel that
this procedure is less invasive, safer, more physiologic and has an
easier learning curve for the surgical treatment of carpal tunnel
syndrome than can be obtained with other
methods.

Balloon Carpal Tunnel-Plasty was developed in the laboratory with
anatomical and biomechanical study. Our investigative group has
successfully performed it over the past five years in over 200 patients
with excellent results.

To be eligible for this study, a patient must be between the ages of 20
to 75 years of age with a positive history of symptoms consistent with
carpal tunnel syndrome of over three months duration. A detailed medical
history is requested which includes a list of any previous medical
illness, previous surgery, medications, allergies and history of any
family illness. A description of the patient's occupation as well as any
precipitating factors that may have exacerbated the patient's condition.
A complete physical examination must be performed documenting positive
clinical findings consistent with the diagnosis of carpal tunnel
syndrome. Recent, within 4 months, positive electrodiagnostic studies
are required, which confirm
median nerve compression at the level of the carpal tunnel.
All patients must sign a fully informed surgical consent to paticipate
in the study which is double blinded comparing Balloon Carpal
Tunnel-Plasty to open carpal tunnel release.

The FDA has reviewed the procedure and given approval for a national
clinical trial.

The study protocol is available at your request.

The study is sponsored by Surgical Dynamics, a division of the United
States Surgical Corporation.

Participating centers:

Orthopaedic Associates, Fair Lawn, New Jersey
The Philadelphia Hand Center, Philadelphia, Pennsylvania
Loyola University Medical Center, Chicago, Illinois
Western Medical, Logan, Utah
Westchester Bone and Joint Associates, North White Plains, New York

If you have a patient that you feel would benefit from the Balloon
Carpal Tunnel-Plasty procedure, please e-mail us at:
Carpaltunnel@hotmail.com

If you would be interested in more information or joining us as an
investigator, please e-mail us at: Carpaltunnel@hotmail.com

Sincerely,
Lee Berger
Orthopaedic Associates
1501 Broadway, Suite 20
Fair Lawn, New Jersey 07410
201-794-6008

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